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Could a simple breathing device help heal hearts after a heart attack?

NCT ID NCT04521699

Symptom relief Sponsor: Mayo Clinic Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study at Mayo Clinic tests whether using a CalmiGo device—a small inhaler-like tool that guides slow breathing and grounding—can improve blood vessel function and reduce heart disease risk in people recovering from a heart attack. One hundred adults in cardiac rehab will either use the device plus standard care or standard care alone for 12 weeks. Researchers will measure changes in blood vessel health, stress markers, and quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
CalmiGo stress management device (a handheld device using guided breathing and grounding techniques)
What this could lead to
If it works, this could point toward a simple, drug-free way to reduce stress and improve heart health after a heart attack.
What could go wrong
This is a small, early-stage study with only 100 participants. The device may not show a clear benefit over standard care, and results may not apply to everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2022

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 18 years of age or older * Ability to use the CamliGo device for 12-weeks * Willingness to complete study questionnaires, blood tests,\& EndoPat testing at the beginning and end of study * Patients who have had a recent MI who will be undergoing clinically indicated Cardiac Rehabilitation * Patients who have had a coronary or structural intervention performed in the cardiac catheterization laboratory within the last month, including: coronary stenting; coronary balloon angioplasty; transcatheter aortic valve replacement; mitral valve interventions; patent foramen ovale closures; alcohol septal ablation; paravalvular leak closure. * Patients being seen in the Chest Pain Clinic for Atypical chest pain Exclusion Criteria: * Cognitively impaired patients * Patient with Bipolar disorder, psychosis or delusional disorder * History of substance abuse or dependence * History of suicidality * Unstable cardiovascular or pulmonary disease * History of seizures * Latex allergy

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Conditions

The condition(s) this trial relates to.

myocardial infarction

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Myocardial infarction

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Mayo Clinic in Rochester

    RECRUITING

    Rochester, Minnesota, 55905, United States

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